MAUDE Adverse Event Report: ENDOLOGIX AFX2; BIFURCATED STENT GRAFT

Model Number	BEA28-120/I16-40
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Aneurysm (1708); Failure of Implant (1924); Pain (1994)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device involved in the event will not be returned for evaluation as it remains implanted in the patient.If additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The patient was initial implanted on (b)(6) 2010 with a bifurcated stent graft and three (3) stent graft extensions the patient returned three (3) years post-initial implant ((b)(6) 2013) with a type 3a endoleak and secondary re-intervention was completed where an aortic extension was placed.On (b)(6) 2018, the patient was presented with a type ii endoleak and another re-intervention occurred where the stent graft was relined with an afx2 bifurcated stent graft and the branches of the right hypogastric artery were coil embolized.All of these event were previously reported.The patient has now presented emergently to the emergency room with pain, where a computerized tomography (ct) scan was performed showing the aneurysm is 15cm in diameter in the presence of a type iiib endoleak.The patient have refused further treatment.The patient has had multiple repairs with a re-line and has elected to go into hospice.The primary device used for this complaint will be from the last intervention where the original graft was relined with afx2 bifurcated stent graft.As of the date of this report, there have been no additional patient sequelae reported.
Additional Manufacturer Narrative
The manufacturing lot evaluation confirmed all devices met specifications prior to release.The device was not returned as the device remains implanted therefore no evaluation was completed.A clinical assessment of the reported event could not be completed due to a lack of receipt of relevant medical records and/or imaging.Several attempts were made to obtain medical records and/ or images but no response was received.As such, event determination, off label conditions, related patient harms and patient disposition could not be independently assessed.No additional investigation of this reported event is planned.Endologix will continue to monitor this complaint and similar complaints in the event further investigation is needed.

• Brand Name: AFX2
• Common Device Name: BIFURCATED STENT GRAFT
• Manufacturer (Section D): ENDOLOGIX; 2 musick; irvine CA 92618
• MDR Report Key: 8072156
• Report Number: 2031527-2018-00861
• Device Sequence Number: 16503715
• Product Code: MIH
• UDI-Device Identifier: 00818009014443
• UDI-Public: (01)00818009014443(17)180718
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2018
• Device Model Number: BEA28-120/I16-40
• Device Lot Number: 1722210-005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AORTIC EXTENSION, LOT # W10-1508-007; AORTIC EXTENSION, LOT # W10-1892-022; AORTIC EXTENSION, LOT # W10-1938-001; BIFURCATED STENT GRAFT, LOT # W10-1863-022; INFRARENAL EXTENSION, LOT # 1026642-011
• Outcome Attributed to Adverse Event: Other